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Study to Validate a Computerized Neuropsychological Test Battery

30. marts 2015 opdateret af: Michael Williams, LifeBridge Health

Reliability and Validity of Umea Computerized Neuropsychological Battery

This study is comparing a new computer-based method of administering neuropsychological tests to the standard method of verbal and paper/pencil tests administered in person by an examiner. The purpose of the research is to determine if the computerized and standard testing methods are equivalent.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Cognitive decline is one of the primary symptom triad of Normal Pressure Hydrocephalus (NPH). Neuropsychological measures have been demonstrated as being effective in the diagnosis of NPH, and in assessing the efficacy of treatment intervention. Hence, neuropsychological assessment is a critical component in the assessment for the presence of NPH. Specifically, measures of attention/concentration, fine motor skills, executive functioning abilities, speed of processing and memory have been found to be useful in the assessment of NPH and treatments thereof.

Neuropsychologists are typically found in large hospitals, academic centers and in urban locations. Neuropsychologists are under represented in rural or low population centers. At the present time, cognitive assessment is frequently limited to a Mini Mental Status Examination. Furthermore, neuropsychological testing can be very expensive for patients, given insurance constraints. Finally, there is no standardized test battery that is used in different centers treating this patient population. The creation of a standard battery that could be used in other NPH centers would promote research collaboration.

A computerized neuropsychological test battery was developed in Umea, Sweden with the specific goal of using tests that are considered to be sensitive to the cognitive profile observed in NPH. The battery was developed in JAVA and Adobe Flash making it platform independent (Runs on Mac, Windows and Linux). The test battery is administered on a touch screen display, where the tests are presented through animations with audio instructions. Before the real test trails are administered, subjects are given practice trials with auditory and visual feedback. For the American version of the test, the auditory stimuli have been translated and recorded in English.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21209
        • Sandra and Malcolm Berman Brain & Spine Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Healthy elderly subjects without significant neurologic, psychiatric, cardiovascular, or other systemic disease that impairs neurologic function or cognitive function

Beskrivelse

Inclusion Criteria:

  • Age 60-80

Exclusion Criteria:

  • Neurological disorder that results in motor or cognitive dysfunction
  • Perceptual or motor difficulties that would prevent subjects from taking the assessment
  • MMSE score <20
  • MoCA score <26
  • MAS score >9
  • Significant abnormal neurologic examination findings

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Computer Hydrocephalus Neuropsychological Assessment Versions 1 & 2
Tidsramme: Within 2-5 weeks of enrollment
Within 2-5 weeks of enrollment
Standard Hydrocephalus Neuropsychological Assessment: Versions 1 & 2
Tidsramme: Within 2-5 weeks of enrollment
Within 2-5 weeks of enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

LifeBridge Health

Efterforskere

  • Ledende efterforsker: Michael A Williams, MD, LifeBridge Health

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2011

Primær færdiggørelse (Faktiske)

1. september 2013

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

19. august 2011

Først indsendt, der opfyldte QC-kriterier

19. august 2011

Først opslået (Skøn)

22. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • BSI-LBH 1735

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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